Class I · High risk Terminated
NitroGlycerin
Reason Subpotent Drug: found to be below the specification for labeled assay.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
NitroGlycerin
Reason Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk Terminated
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Reason Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk Terminated
Andropharm M1 Alpha
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk Terminated
Andropharm Sten Z
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk Terminated
EliquisTablets 5mg
Reason Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
Class I · High risk Terminated
Paliperidone Extended-Release Tablets
Reason Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Class I · High risk Terminated
CaverFlo Natural Herbal Coffee
Reason Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Class I · High risk Terminated
Brilinta
Reason Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Class I · High risk Terminated
Biotech Underground Tri-Ton Hardcore Formula capsules
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
Class I · High risk Terminated
Mibelas 24 Fe
Reason Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Class I · High risk Terminated
GEC LX Laxoplex 60 capsules Dietary Supplement
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
Class I · High risk Ongoing
Infant 25% DEXTROSE Injection
Reason Presence of Particulate Matter: human hair found within an internal sample syringe.
Class I · High risk Terminated
Phenobarbital Tablets USP
Reason Labeling: Label Mixup; potentially mislabeled
Class I · High risk Terminated
Phenobarbital Tablets USP
Reason Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Class I · High risk Terminated
LabidaMAX Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
ZRECT for Women Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
ENHANCEROL Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
TORNADO Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
RECTALIS Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
Xrect Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
ZRECT Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
Cummor Natural Male Enhancement
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin